Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000325404p
Ethics application status
Submitted, not yet approved
Date submitted
2/04/2025
Date registered
17/04/2025
Date last updated
17/04/2025
Date data sharing statement initially provided
17/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Breathwork on Physiological Stress Regulation and Performance in Emergency Responders: An Experimental Controlled Simulation Trial
Scientific title
The Effect of Breathwork on Physiological Stress Regulation and Performance in Emergency Responders: An Experimental Controlled Simulation Trial
Secondary ID [1] 313548 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
Sub-study linked to ACTRN12625000101482

Health condition
Health condition(s) or problem(s) studied:
Autonomic nervous system dysregulation 336904 0
Stress-related physiological responses 336903 0
Condition category
Condition code
Alternative and Complementary Medicine 333373 333373 0 0
Other alternative and complementary medicine
Mental Health 333374 333374 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From a previous study, 15 paramedicine students from the Breathwork group and 15 paramedicine students from the control group will be selected to don Hexoskin apparatus and participate in stressful immersive simulations. Hexoskin apparatus will measure heart rate (HR), respiratory rate (RR), and heart rate variability (HRV) during fully immersive stressful simulations such as a simulated paediatric cardiac arrest.
The paramedicine students (n=30), they will undergo identical acutely stressful one-day scenarios designed by their university staff. Performance will be independently judged as an additional outcome.
Participation in the previous study ACTRN12625000101482 is a key inclusion criterion.

The Hexoskin smart shirt is a wearable biometric monitoring garment designed to collect real-time physiological data including heart rate, respiratory rate, and HRV. Participants will wear the Hexoskin shirt beneath their uniform for the duration of each simulation. The garment connects to a companion device worn at the waist and transmits data wirelessly to a secure database for analysis. Participants will wear the device for approximately 10 minutes pre-simulation (rest period), throughout the simulation (~20 minutes), and for a 10-minute post-simulation cool-down period.

The intervention group will be instructed in the A52 Method (aka “Little A Method”) of breathwork: a daily 10-minute session involving slow, diaphragmatic nasal breathing with a 5-second inhale, 5-second exhale, and 2-second pause (hold), performed while seated and relaxed. The intervention group members will be asked to practice the A52 Method frequently (i.e. twice per day), 7 days leading up to the simulation task.

Simulation:
Each participant will participate in one simulation that will last upto 20 minutes.
The participant will enter the simulation by themselves and participate in a scenario such as a paediatric arrest.
Participants will wear the Hexoskin for 10 minutes pre-simulation (rest baseline), during the simulation, and for 10 minutes post-simulation (recovery period).
No separate rest protocol is administered outside these time points.
Simulations will be conducted by senior paramedic educators trained in high-fidelity simulation delivery.
Simulations will be observed through two way glass.

This study builds upon the trial registered under ACTRN12625000101482.
Intervention code [1] 330684 0
Prevention
Comparator / control treatment
The control group will not have received the breathwork intervention. Participants in the control group will continue with their usual routine without any additional practices introduced. They will complete the same pre- and post-study assessments as the intervention group for comparison purposes.

For the purposes of this study, "usual routine" refers to the participants’ normal daily activities and habits, without the introduction of any structured breathwork or stress-reduction interventions. Control group participants will not be instructed to modify their breathing, engage in mindfulness, or adopt any new physical or mental health practices during the study period.

Acceptable routines that do not conflict with the control group's purpose may include:

Attending university classes or clinical placements as usual

Engaging in regular exercise (e.g., gym, walking, sports)

Practicing general wellness behaviours (e.g., healthy eating, sleep hygiene)

Engaging in social or leisure activities

Receiving support from existing counselling services (as long as no breathwork or guided stress-reduction techniques are introduced)

Participants will be asked to avoid initiating any new stress-reduction programs, meditation, yoga, or breathwork routines for the duration of the trial.
Control group
Active

Outcomes
Primary outcome [1] 340943 0
Heart rate variability (HRV)
Assessment method [1] 340943 0
Measured via Hexoskin suit during rest and/or stress protocols.
Timepoint [1] 340943 0
Data will be collected at three time points: 1. Baseline (Pre-simulation) 10 minutes 2. During simulation (Stress exposure) 20 minutes 3. Post-simulation (Recovery phase) 10 minutes
Primary outcome [2] 340944 0
Respiratory rate
Assessment method [2] 340944 0
Respiratory rate will be continuously monitored via the Hexoskin smart garment. While the primary outcome of interest is respiratory rate response during the stress simulation protocols, heart rate data will also be collected during the 10-minute pre-simulation rest period and the 10-minute post-simulation recovery period to allow for analysis of baseline, reactivity, and recovery patterns. No respiratory rate data will be collected outside of these scheduled sessions.
Timepoint [2] 340944 0
Data will be collected at three time points: 1. Baseline (Pre-simulation) 10 minutes 2. During simulation (Stress exposure) 20 minutes 3. Post-simulation (Recovery phase) 10 minutes
Primary outcome [3] 340945 0
Heart Rate
Assessment method [3] 340945 0
Heart rate will be continuously monitored via the Hexoskin smart garment. While the primary outcome of interest is heart rate response during the stress simulation protocols, heart rate data will also be collected during the 10-minute pre-simulation rest period and the 10-minute post-simulation recovery period to allow for analysis of baseline, reactivity, and recovery patterns. No heart rate data will be collected outside of these scheduled sessions.
Timepoint [3] 340945 0
Data will be collected at three time points: 1. Baseline (Pre-simulation) 10 minutes 2. During simulation (Stress exposure) 20 minutes 3. Post-simulation (Recovery phase) 10 minutes
Secondary outcome [1] 445545 0
Self-reported perception of intervention effectiveness
Assessment method [1] 445545 0
Measured via post-intervention questionnaire assessing subjective experience (e.g. perceived benefits, consistency, challenges). This questionnaire was designed specifically for the study.
Timepoint [1] 445545 0
Time point: Post-simulation (10 minutes)
Secondary outcome [2] 445546 0
Performance
Assessment method [2] 445546 0
Assessed by an independent assessor. Assessors will assign a single score (1-10) based on a participant’s overall performance in completing tasks, decision-making, and handling stress. This scale was developed specifically for this study.
Timepoint [2] 445546 0
Post-simulation up to 10 minutes.

Eligibility
Key inclusion criteria
Inclusion Criteria: subjects from the previous study (ACTRN12625000101482) who committed to practicing their breathwork technique over 50%, can commit to the intervention or control simulation schedule, capable of providing informed consent, can speak and read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria: participants without restricting medical conditions, gravid females, participants prescribed heart rate limiting medications, specifically, beta blockers and/or calcium channel blockers.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/07/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318617 0
University
Name [1] 318617 0
Griffith University
Country [1] 318617 0
Australia
Primary sponsor type
University
Name
Griffith University
Country
Australia
Secondary sponsor category [1] 321022 0
None
Name [1] 321022 0
Country [1] 321022 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316670 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 316670 0
Ethics committee country [1] 316670 0
Australia
Date submitted for ethics approval [1] 316670 0
03/03/2025
Approval date [1] 316670 0
Ethics approval number [1] 316670 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 138602 0
Ms Abbie Little
Address 138602 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138602 0
Australia
Phone 138602 0
+61 417128159
Email 138602 0
abbie.little@griffithuni.edu.au
Contact person for public queries
Name 138603 0
Abbie Little
Address 138603 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138603 0
Australia
Phone 138603 0
+61 417128159
Email 138603 0
abbie.little@griffithuni.edu.au
Contact person for scientific queries
Name 138604 0
Abbie Little
Address 138604 0
Griffith University - 1 Parkland Drive, Southport, QLD 4215
Country 138604 0
Australia
Phone 138604 0
+61 417128159
Email 138604 0
abbie.little@griffithuni.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: abbie.little@griffithuni.edu.au

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.